Evaluation of Trazodone in OSA-MCI

Obstructive Sleep Apnea Clinical Trial

Official title:

Randomized-Controlled Trial of Trazodone on Reducing Plasma sST2 Level and Neurodegeneration Progression in Patients With Amnestic Mild Cognitive Impairment and Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209035
• Other study ID #: 2021.038
• Status: Recruiting
• Phase: Phase 4
• Start date: May 10, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2022
• Source: Chinese University of Hong Kong
• Contact: Timothy Kwok
• Phone: +852 3505 3173
• Email: tkwok[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD. A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Able to swallow trazodone capsules
• Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening
• A diagnosis of mild cognitive impairment (MCI)
• A diagnosis of obstructive sleep apnea (OSA), and Apnea-Hypopnea Index > 5
• Neuroimaging obtained during screening consistent with a clinical diagnosis of Alzheimer's disease (AD) and without findings of significant exclusionary abnormalities
• Written informed consent to participate in the study provided by the patient

Exclusion Criteria:

• Diagnosis of dementia, neurodegenerative condition, seizure disorder or other infectious, metabolic, or systemic disease affecting the central nervous system
• Vitamin B12 or folate deficiency
• Diagnosis of mental health disorders
• Nootropic drugs except for AD prescriptions stable for at least 30 days
• Suspected or known allergy to trazodone
• Intake of drugs or substances potentially involved in clinically significant inhibition or induction of CYP34A or P-gp-medicate drug interactions with trazodone within 4 weeks or 5 half-lives of the interacting drug prior to administration of trazodone and throughout the course of the study
• Previous exposure to anti-Aß vaccines
• Concurrent treatment with antipsychotic agents, antiepileptics centrally active antihypertensive drugs, sedatives, opioids, mood stabilizers, or benzodiazepines within 4 weeks of screening visit
• Patients who are receiving non-benzodiazepine hypnotics
• Clinically significant, advanced, or unstable disease that might interfere with outcome evaluations

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Trazodone
Trazodone 50mg daily

Other:
• Placebo
Starch 50mg

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Hong Kong University of Science and Technology

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sST2	The change of plasma sST2 levels	Baseline, Week 4, 13, 26 and 52
Primary	Clinical Dementia Rating Score	The change in Clinical Dementia Rating global score	Baseline, Week 26 and 52